An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
- Trial number:
- NCT05952557
- Trial phase:
- 3
- Study type:
- Hormonal therapy
- Overall status:
- Recruiting
Study start date
October, 2023
Scientific title
CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease
Summary
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.
Women and Men; ≥18 years at the time of screening (or per national guidelines)Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease as defined in the protocol. Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy. Patients must be randomised within 12 months of definitive breast surgery. Patients may have received up to 12 weeks of endocrine therapy prior to randomisation. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 Adequate organ and bone marrow function
Study design
Primary purpose:
Treatment, Allocation:
Randomized, Intervention model:
Parallel Assignment, Intervention model description:
Patients will be randomised in a 1:1 ratio to one of the following arms, Masking:
None (Open Label),
Conditions
Breast Cancer, Early Breast Cancer
Other study ID numbers
D8535C00001; 2023-504031-41-00